LH Hormone Pulsation in the Luteal Phase in GnRH Antagoni... | NCT02449642

Studies
LH Hormone Pulsation in the Luteal Phase in GnRH Antagonist IVF Cycles Triggered by GnRH Agonist for Final Oocyte Maturation

NCT02449642

Sponsor

Rambam Health Care Campus

Status

Completed

Last Update Posted

Aug 18, 2015Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Infertility

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

May 16, 2015

First Submission Date that Met QC Criteria

May 19, 2015

First Posted Date

May 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2015

Last Update Posted Date

Aug 18, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Monitoring the LH pulsatility during the Luteal phase in GnRH antagonist IVF cycles triggered by GnRH agonist for final oocyte maturation.

Detailed Description

About two decades ago the GnRH antagonist has been used in IVF cycles to prevent premature LH surge. In recent review GNRH antagonist has been found comparable to GnRH agonist in term of live birth rate but with reduced risk of OHSS. another advantage of using GnRH antagonist is the ability to use GnRH agonist for final oocyte maturation which has been shown to nearly eliminate the risk of OHSS. The exact mechanism of this risk reduction is still unknown.

Our aim is to do a frequent blood tests every 20 minutes for 6 hours duration in the day of ovum pick up or the day of embryo transfer to measure the level of LH, estradiol and progesterone in women triggered with GnRH agonist for final oocyte maturation.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group 1		group 1 include 10 women in which blood tests will be taken on the day of oocyte pick up
group 2		group 2 include 10 women in which blood tests will be taken on the day of embryo transfer

Interventions

Not provided

Measure	Description	Time Frame
luteinizing hormone pulsatility frequency		6 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age: 18-42 years old BMI < 32 kg/m2

Exclusion Criteria:

Hypogonadotropic hypogonadism

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

women aged 18-42 years old BMI < 32 kg/M2

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rambam medical center, IVF unit		Haifa	Israel	31096	Israel

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

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Browse Branches

Not provided